Genetic engineering in North America is any genetic engineering activities in North America
As of 2002 the United States, Canada, and Mexico do not require labeling of genetically modified foods.[1]
Canada
Mainland Canada is one of the world's largest producers of GM canola[2] and also grows GM maize, soybean and sugarbeet.[3] Health Canada, under the Food and Drugs Act, and the Canadian Food Inspection Agency[4] are responsible for evaluating the safety and nutritional value of genetically modified foods. Environmental assessments of biotechnology-derived plants are carried out by the CFIA's Plant Biosafety Office (PBO).[5] The Canadian regulatory system is based on whether a product has novel features regardless of method of origin. In other words, a product is regulated as GM if it carries some trait not previously found in the species whether it was generated using traditional breeding methods (e.g. selective breeding, cell fusion, mutation breeding) or genetic engineering.[6][7][8] Canadian law requires that manufacturers and importers submit detailed scientific data to Health Canada for safety assessments for approval. This data includes: information on how the GM plant was developed; nucleic acid data that characterizes the genetic change; composition and nutritional data of the novel food compared to the original non-modified food' potential for new toxins; and potential for being an allergen. A decision is then made whether to approve the product for release along with any restrictions or requirements. Labeling of foods as products of Genetic Engineering or not products of Genetic Engineering is voluntary.[8][9] The Canadian regulations were reviewed by the Canadian Biotechnology Advisory Committee between 1999 and 2003, with the conclusion that the current level of regulation was satisfactory. The committee was accused by environmental and citizen groups of not representing the full spectrum of public interests by only having one member of the board of 20 representing non-governmental organisations and for being too closely aligned to industry groups.[10]
Mexico
In February 2005, after consulting the Mexican Academy of Sciences, Mexico's senate passed a law allowing to plant and sell genetically modified cotton and soybean.[11] The law requires all genetically modified products to be labelled according to guidelines issued by the Mexican Ministry of Health. In 2009, the government enacted statutory provisions for the regulation of genetically modified maize.[12] Mexico is the center of diversity for maize and concerns had been raised about the impact genetically modified maize could have on local strains.[13][14] In 2013, a federal judge ordered Mexico's SAGARPA (Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca, y Alimentación), which is Mexico's Secretary of Agriculture, and SEMARNAT (Secretaría de Medio Ambiente y Recursos Naturales), equivalent of the EPA, to temporarily halt any new GMO corn permits, accepting a lawsuit brought by opponents of the crop.[15]
United States
Federal regulation
The USA is the largest commercial grower of genetically modified crops in the world.[16]
United States regulatory policy is governed by the Coordinated Framework for Regulation of Biotechnology[17] This regulatory policy framework that was developed under the Presidency of Ronald Reagan to ensure safety of the public and to ensure the continuing development of the fledgling biotechnology industry without overly burdensome regulation.[18] The policy as it developed had three tenets: "(1) U.S. policy would focus on the product of genetic modification (GM) techniques, not the process itself, (2) only regulation grounded in verifiable scientific risks would be tolerated, and (3) GM products are on a continuum with existing products and, therefore, existing statutes are sufficient to review the products."[18] In 2015 the Obama administration announced that it would update the way the government regulated genetically modified crops.[19]
For a genetically modified organism to be approved for release, it must be assessed under the Plant Protection Act by the Animal and Plant Health Inspection Service (APHIS) agency within the US Department of Agriculture (USDA) and may also be assessed by the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA), depending on the intended use of the organism. The USDA evaluates the plant's potential to become a weed. The FDA has a voluntary consultation process with the developers of genetically engineered plants. The Federal Food, Drug, and Cosmetic Act, which outlines FDA's responsibilities, does not require pre-market clearance of food, including genetically modified food plants.[20][21] The EPA regulates genetically modified plants with pesticide properties, as well as agrochemical residues.[22] Most genetically modified plants are reviewed by at least two of the agencies, with many subject to all three.[23][24] Within the organization are departments that regulate different areas of GM food including, the Center for Food Safety and Applied Nutrition (CFSAN, ) and the Center for Biologics Evaluation and Research (CBER).[22] As of 2008, all developers of genetically modified crops in the US had made use of the voluntary process.[25] Final approval can still be denied by individual counties within each state. In 2004, Mendocino County, California became the first county to impose a ban on the "Propagation, Cultivation, Raising, and Growing of Genetically Modified Organisms", the measure passing with a 57% majority.[26] In May, 2014 Jackson and Josephine Counties in Southern Oregon passed initiatives similar to that passed by Mendocino County; both passing by 2 to 1 margins.[27]
Several laws govern the US regulatory agencies. These laws are statutes the agencies review when determining the safety of a particular GM food. These laws include:[22]
- The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (EPA);
- The Toxic Substances Control Act (TSCA) (EPA);
- The Federal Food, Drug, and Cosmetic Act (FFDCA) (FDA and EPA);
- The Plant Protection Act (PPA) (USDA);
- The Virus-Serum-Toxin Act (VSTA) (USDA);
- The Public Health Service Act (PHSA)(FDA);
- The Dietary Supplement Health and Education Act (DSHEA) (FDA)
- The Meat Inspection Act (MIA)(USDA);
- The Poultry Products Inspection Act (PPIA) (USDA);
- The Egg Products Inspection Act (EPIA) (USDA); and
- The National Environmental Policy Act (NEPA).
State regulation
Several states have passed regulations concerning labelling of GM food; Connecticut passed a GMO labeling bill in May 2013, but the bill will only be triggered after four other states enact similar legislation.[28] On January 9, 2014, Maine’s governor signed a bill requiring labeling for foods made with GMO's, with a similar triggering mechanism as Connecticut's bill.[29] In May 2014 Vermont passed a law requiring labeling of food containing ingredients derived from genetically modified organisms.[30][31] A federal judge ruled Maui's GMO ban invalid.[32]
References
- ↑ Trade barriers seen in EU label for bio-engineered ingredients. (Regulatory and Policy Trends). Business and the Environment 13.11 (Nov 2002): p14(1).
- ↑ GMO Compass Rapeseed Archived 2017-03-29 at the Wayback Machine July 27, 2010. Retrieved 6 August 2010.
- ↑ "Slides & Tables : Global Status of Commercialized Biotech/GM Crops: 2010 - ISAAA Brief 42-2010 - ISAAA.org".
- ↑ "Information for the general public". 2015-03-20.
- ↑ "Genetically Modified Foods". The Canadian Encyclopedia. Retrieved August 27, 2019.
- ↑ Evans, Brent and Lupescu, Mihai (15 July 2012) Canada - Agricultural Biotechnology Annual – 2012 Archived 2013-12-15 at the Wayback Machine GAIN (Global Agricultural Information Network) report CA12029, United States Department of Agriculture, Foreifn Agricultural Service, Retrieved 2 November 2012.
- ↑ McHugen, Alan (September 14, 2000). "Chapter 1: Hors-d'oeuvres and entrees/What is genetic modification? What are GMOs?". Pandora's Picnic Basket. Oxford University Press. ISBN 978-0198506744.
- 1 2 Canadian Biotechnology Advisory Committee (CBAC), Consultation Document 2001: Regulation of Genetically Modified Food, page 2, Definition of "Genetically Modified": "The term “genetically modified foods” (GM foods) refers to foods that have been produced using recent advances in gene technology, such as gene cloning, genesplicing and plant transformation." Retrieved August 27, 2019. Cf. also version 2013. Cf. Health Canada, definition
- ↑ Staff (20 July 2012) Voluntary Labelling and Advertising of Foods that are and are not Products of Genetic Engineering Public Works and Government Services Canada, National Standard of Canada, Retrieved 1 November 2012. Reaffirmed 2016
- ↑ Prudham, Scott; Morris, Angela (1 January 2006). "Making the Market "Safe" for GM Foods: The Case of the Canadian Biotechnology Advisory Committee". 78 – via spe.library.utoronto.ca.
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(help) - ↑ SciDev.Net. "Mexico approves planting and sale of GM crops".
- ↑ "Mexico: controlled cultivation of genetically modified maize". Archived from the original on 2013-10-05. Retrieved 2017-08-15.
- ↑ Mike Shanahan Warning issued on GM maize imported to Mexico - SciDev.Net 10 November 2004
- ↑ Katie Mandell GM maize found ‘contaminating’ wild strains - SciDev.Net 30 November 2001
- ↑ David Alire Garcia (12 November 2013). "Past and future collide as Mexico fights over GMO corn". Reuters. Retrieved 9 September 2015.
- ↑ Clive James (2009). "ISAAA Brief 41-2009: Executive Summary: Global Status of Commercialized Biotech/GM Crops The first fourteen years, 1996 to 2009".
- ↑ "United States Regulatory Agencies Unified Biotechnology Website". Archived from the original on 2012-11-17.
- 1 2 Emily Marden, Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture 44 B.C.L. Rev. 733 (2003)
- ↑ Pollack, Andrew (2015-07-02). "White House Orders Review of Rules for Genetically Modified Crops". The New York Times. ISSN 0362-4331. Retrieved 3 July 2015.
- ↑ "FDA page for Q & A on GM Food". fda.gov. Retrieved 15 August 2017.
- ↑ "FDA page on Regulation of GM Plants in Animal Feed". fda.gov. Retrieved 15 August 2017.
- 1 2 3 "Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products" (PDF). The Pew Initiative on Food and Biotechnology. Washington, DC: The Pew Charitable Trusts. 2001. Retrieved 2 June 2012.
- ↑ McHughen A, Smyth S (2008). "US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars". Plant Biotechnology Journal. 6 (1): 2–12. doi:10.1111/j.1467-7652.2007.00300.x. PMID 17956539.
- ↑ "Consultation Procedures under FDA's 1992 Statement of Policy - Foods Derived from New Plant Varieties". FDA. October 1997 [June 1996].
- ↑ Peggy G. Lemaux Genetically Engineered Plants and Foods: A Scientist's Analysis of the Issues (Part I) Annual Review of Plant Biology 59: 771-812 DOI: 10.1146/annurev.arplant.58.032806.103840. Quote: "Although GE foods can be marketed without certain regulatory approvals, to date all products in the marketplace have undergone full review by regulatory agencies regarding safety and content relative to unmodified forms (searchable data on specific events available at 84). Submitting the safety data is in the developer's best interests, however, given the legal liabilities incurred should a problem with the food arise following market introduction"
- ↑ Marygold Walsh-Dilley (2009) "Localizing control: Mendocino County and the ban on GMOs" Agriculture and Human Values 26(1-2):95-105
- ↑ http://www.co.jackson.or.us/page.asp?navid=3967, http://www.co.josephine.or.us/files/17-58ballottitlewebsite.pdf, http://www.kgw.com/news/politics/genetically-modified-foods-260011131.html. Archived May 16, 2014, at the Wayback Machine
- ↑ Reilly, Genevieve (11 December 2013). "Malloy signs state GMO labeling law in Fairfield". ctpost.com. Retrieved 7 March 2014.
- ↑ Herling DJ, Mintz L, Cohn FG, Popeo PC (12 January 2014). "As Maine Goes, So Goes The Nation? Labeling for Foods Made with Genetically Modified Organisms (GMOs)". The National Law Review. Retrieved 8 March 2014.
- ↑ Terri Hallenbeck, for the Burlington Free Press. April 27, 2014 How GMO labeling came to pass in Vermont
- ↑ Terri Hallenbeck for The Burlington Free Press. May 8, 2014 Vermont gov signs law to require labels on GMO foods
- ↑ staff (June 30, 2015). "Federal judge rules Maui GMO ban invalid".